MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number VPR-GW-FLEX14

Device Problem Entrapment of Device (1212)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

Csi is attempting to reach out to the physician involved in this case for additional information.As of now, the results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.If additional relevant information is received from the physician, a supplemental report will be submitted.The device history record for the reported oad could not be reviewed, as the lot number was not provided.If the lot number is provided, a dhr review will be performed.(b)(4).

Event Description

The peripheral orbital atherectomy device (oad) became stuck in the tibial artery during use.A dissection and perforation occurred.Angioplasty was performed to resolve the issue.

Event Description

The opinion of the physician is that the viperwire used in the procedure damaged the vessel.

Manufacturer Narrative

Additional data: b5, d4, h4, updated data: b4, g3.Csi id: (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 11421455
• MDR Text Key: 234925826
• Report Number: 3004742232-2021-00070
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 306961
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1